FDA WARNING_LETTER - kosher foods unlimited, inc. - February 14, 2013

On April 19, 2013, the FDA issued a Warning Letter to Kosher Foods Unlimited, Inc. following an inspection from February 11-14, 2013. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123), rendering their refrigerated ready-to-eat tuna salad products, including sandwiches, adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Inadequate Hazard Analysis:** The firm's HACCP plan for refrigerated Ready-to-Eat Products, specifically tuna salad, failed to list undeclared allergens and histamine formation as food safety hazards, violating 21 CFR 123.6(a) and (c)(1). The firm's response to add allergens was noted, but a revised plan was not provided. 2. **Failure to Implement Monitoring Procedures:** The firm did not follow its own monitoring procedure for tuna salad product at a critical control point (CCP), violating 21 CFR 123.6(b). No documentation of recent monitoring was provided. 3. **Lack of Sanitation Control Records:** The firm failed to maintain sanitation monitoring records for any of the eight key sanitation conditions and practices required for tuna salad processing, violating 21 CFR 123